SBIR Phase I: Development of a Novel, Sprayable, Large Volume Hydrogel Delivery System Platform

该小型企业创新研究（SBIR）I期项目的更广泛影响/商业潜力是一种简化系统，用于在手术过程中原位应用化合物形成生物材料。受控生物材料应用带来了显著的潜在外科优势，包括用于抗粘连、组织密封剂和药物递送目的。拟议的平台将实现手术一致性，以提供新的和改进的方法来管理出血并减少手术过程中的瘢痕组织形成。该产品旨在从15亿美元的防粘连市场和12亿美元的止血剂市场中分得一杯羹，并根据所输送的生物材料，实现最终的位点特异性输送细胞和药物。这个小企业创新研究（SBIR）第一阶段项目将开发一种即用型大容量输送系统，用于原位形成生物材料。活动范围包括将一种新型、专有、原位生物材料（适用于作为组织封闭剂、瘢痕组织还原剂和药物/细胞递送载体）转移到一种新型一次性施用器中。预包装的递送系统将使用内部机械机构用再悬浮溶液配制悬浮的生物材料，该内部机械机构以适于临床使用的受控雾化方式递送生物材料。 这个第一阶段项目的目的是完成和验证的冻干生物材料的原型在良好的生产实践中，工程师的注射器筒和输送头/喷嘴的设计，并完成实验室验证的方式适合首次在人类使用。这个奖项反映了NSF的法定使命，并已被认为是值得通过评估使用基金会的智力价值和更广泛的影响审查标准的支持。

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) Phase I project is a simplified system for applying compound in situ to form biomaterials during surgical procedures. Controlled biomaterial applications pose significant potential surgical advantages including for anti-adhesion, tissue sealant, and drug delivery purposes. The proposed platform will enable procedural consistency to provide new and improved ways to manage bleeding and reduce scar tissue formation during surgical procedures. This product aims to gain a share of the $1.5 billion adhesion prevention market and $1.2 billion hemostat market, and enable eventual site-specific delivery cells and drugs, depending on the biomaterial delivered. This Small Business Innovation Research (SBIR) Phase I project will develop a ready-to-use, large volume delivery system for in situ forming biomaterials. The scope of activities includes transferring a novel, proprietary, in situ biomaterial with applicability as a tissue sealant, scar tissue reductant, and drug/cell delivery vehicle, into a novel single use applicator. The prepackaged delivery system will formulate the suspended biomaterial with the resuspension solution using an internal mechanical mechanism which delivers the biomaterial in a controlled aerosolized manner suitable for clinical use. This Phase 1 project aims to complete and validate prototypes with lyophilized biomaterials within good manufacturing practices, engineer the design of the syringe barrel and delivery tips/nozzles, and complete laboratory validation in a manner suitable for first in human use.This award reflects NSF's statutory mission and has been deemed worthy of support through evaluation using the Foundation's intellectual merit and broader impacts review criteria.